SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients

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This is a 28-day, multi-center, placebo-controlled study designed to look at the dose response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of HIV-infected subjects.

Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated in the pathogenesis of HIV. It has also been established that drugs of this nature exert an anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus replication.

One measurement of an HIV infected person’s risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a “viral load”). This study is designed to see if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if he/she is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient).

Study drug administration will continue for 28 days. At the end of the 28-day study, the patient will be offered testing of his/her virus for resistance to approved drugs (genotype).

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Orally Administered SP01A for 28 Days as Monotherapy Treatment in HIV-Infected Patients With Evidence of Resistance to Currently Available Antiretroviral Therapy

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Prior to the first day of study drug:

Patient must be capable of giving informed consent prior to the screening visit.

Patient is HIV-positive and has treatment-experienced virologic failure or documented resistance. Treatment-experienced virologic failure is defined as patients meeting the following criteria; (1) previous experience with antiretroviral therapy from at least two of the approved antiretroviral classes (i.e. treatment with a nucleoside reverse transcriptase inhibitor, and/or non-nucleoside reverse transcriptase inhibitor, and/or protease inhibitor) for three to six months; (2) increasing HIV RNA after treatment had previously lowered viral load to low or undetectable levels; (3) increased viremia (HIV RNA > 5,000 copies/mL) in at least two viral load tests, one of which can be the screening viral load test, confirming their failing regimen. A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA < 5,000 copies/mL) is not eligible for entry into the study.

Patient has been off all antiviral medications including any unapproved or experimental treatment for at least 2 weeks prior to Study Day-1 (baseline).

Patient has not taken any experimental medications for at least 4 weeks prior to Screening.

Patient is at least 18 years of age and not older than 60 years of age.

Patient is capable of adhering to the protocol.

Patient has a CD4+ count >/= 100 copies/mL.

Patient has a viral load of > 5000 copies/mL.

Patient has a Karnofsky score >/= 60.

Female patients that are of childbearing potential; (1) have a negative urine pregnancy test at screening, and agree to use a condom and another form of contraception (dual contraception) from the start of the study; or (2) are incapable of becoming pregnant.

Exclusion Criteria:

Patients are ineligible to participate in the study if ANY of the following criteria are met.

Patients with known or suspected allergy to procaine hydrochloride.

Patients that must take oral or injectable anticholinesterase inhibitors (alone or in combination) for the treatment of myasthenia gravis or as a reversal agent or antagonist to nondepolarizing muscle relaxants such as curariform drugs. Patients using eye medications for glaucoma are not excluded from the study.

Patients with SGOT (AST) baseline value >3 times upper limit.

Patients with SGPT (ALT) baseline value >3 times upper limit.

Patients with Creatinine >2.0 mg/dl.

Patients with Absolute Neutrophil count <1,000 cells/mm3.

Patients with Platelets baseline value <75,000 cells/µl.

Patients that currently have any active opportunistic infection. Prophylaxis for MAI, CMV, PCP, or Herpes is permitted.

Females that are pregnant or breast feeding.

Female patients of childbearing age who cannot either use dual contraception or abstain from sexual intercourse during the clinical study.

Patients with less than 6 months life expectancy.

Patients with active hepatitis (viral or drug induced).

Patients with cancer, except peripheral (dermal) Kaposi’s sarcoma.

Patients on dialysis.

Patients that currently have an active alcohol or substance abuse.

Patients with any medical, psychological, psychiatric or substance use problem that, in the opinion of the principal investigator, will interfere with the patient’s ability to complete the study.

A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA < 5,000 copies/mL) is not eligible for entry into the study.